NPseal (20和25)
K号: K241522 · 2024-08-15
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决定日期2024-08-15
产品代码OKO
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
NPseal (20 and 25) is the device name listed in this FDA 510(k) record. The listed applicant is Guard Medical, Inc.. It received FDA 510(k) clearance on 2024-08-15 under 510(k) number K241522. The device is classified under product code OKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NPseal (20 and 25)?
NPseal (20 and 25) is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is Guard Medical, Inc.. The 510(k) number is K241522.
When did NPseal (20 and 25) receive FDA 510(k) clearance?
NPseal (20 and 25) received FDA 510(k) clearance on 2024-08-15, under 510(k) number K241522.
Who is the listed applicant for NPseal (20 and 25)?
The FDA 510(k) record lists Guard Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NPseal (20 and 25)?
The FDA product code for NPseal (20 and 25) is OKO.
相关临床试验
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列明Guard Medical, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：OKO）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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